South Korea Premarket Pathway Decision Tree: Four Elements in Order

1. Key takeaways

Korean premarket pathways are determined jointly by 4 elements: device class, availability of substantial equivalence, KGMP status, and whether the product is a digital medical product. The four elements are judged in a fixed order, and the conclusion on any one of them changes the downstream pathway and timeline.

The order of judgment is: first confirm whether the product is a digital medical product (the Digital Medical Products Act took effect for digital medical devices on 24 January 2025 and extends to digital medical and health support devices from 24 January 2026); second assign the class under Annex 1 of the Enforcement Rule; third judge whether substantial equivalence can be established through the six-element comparison; fourth confirm KGMP applicability and status by class. When the four steps are done, the pathway (item notification, item certification, or item approval), the receiving body, the statutory review period, and the official fees are all fixed at the same time.

GRZAN fixes this order as a decision tree not to simplify the judgment but to prevent skipped steps. The most common schedule overruns in projects stem from committing to a timeline before the class has been confirmed.

2. Legal basis

The decision framework rests on the following instruments.

Class-to-pathway mapping (under the Medical Device Act, the Enforcement Rule annex, and MFDS Public Notice No. 2022-52)

3. Expert insights

The digital medical product determination must come first. The Digital Medical Products Act took effect for digital medical devices on 24 January 2025 and extends to digital medical and health support devices from 24 January 2026. If a product falls within the Act’s scope, its classification, documentation, and procedure all follow that Act, and classifying it under the class table of the Medical Device Act is then a misuse. GRZAN puts this step at the top of the decision tree because it decides which statute applies, not which pathway to take.

Class fixes the pathway; substantial equivalence only affects documentation depth. Once the class is fixed, the pathway, body, period, and fees are fixed; the availability of substantial equivalence does not change the pathway, only how the technical documents are organized and how deep the argumentation runs. Confusing these two elements leads companies to try to adjust the class determination in pursuit of simpler documents, which is a directional error. GRZAN issues the class conclusion and the substantial equivalence conclusion separately, each reviewed independently.

KGMP is a parallel line, not a later step. KGMP is mandatory for Classes 2-4 and the certificate is valid for 3 years. It runs in parallel with technical document review; treating it as something to handle after approval stretches the project significantly. GRZAN includes KGMP status as the fourth element of the decision tree not for ordering’s sake, but as a reminder: on the day the pathway is fixed, confirm whether KGMP is already in place and, if not, which audit type fills the gap (one of the 4 types: initial, additional, change, or periodic).

The decision tree’s output is a parameter table, not a single conclusion. Once the four elements are judged, the output should be the parameter combination of pathway, body, period, fees, and KGMP status, not a bare verdict of feasible. GRZAN delivers this parameter table at the project kickoff, giving every later time commitment, budget estimate, and deficiency plan a verifiable baseline. Any change to a parameter value triggers a pathway review.

4. Practical recommendations

• Judge strictly in the four-step order, with no skipped steps. Digital medical applicability, then class, then substantial equivalence, then KGMP status.
• Issue the class conclusion and the substantial equivalence conclusion separately. The former fixes pathway and fees, the latter only affects documentation depth; keep them from interfering with each other.
• Confirm KGMP status on the day the pathway is fixed. If not in place, name the audit type needed (one of the 4 types).
• Fix the decision result as a parameter table. List pathway, body, period, fees, and KGMP status as the baseline for all subsequent estimates.
• Trigger a pathway review when parameters change. When the class is adjusted, the comparator device falls away, or the KGMP certificate expires, walk the decision tree again.
• Record all periods on the working-day basis. The 5, 25, 55, and 70 figures are all working-day values; mixing them with calendar days is a common scheduling error.

5. Verification checklist

• □ Digital medical applicability — checked against the scope and effective dates of the Digital Medical Products Act; standard: a definite conclusion traceable to the staged effect dates of 24 January 2025 and 24 January 2026.
• □ Class determination — cross-checked against Article 3 of the Medical Device Act and Annex 1 of the Enforcement Rule; standard: the class conclusion is traceable to a numbered classification rule.
• □ Pathway and body — mapped by class against notification, certification, and approval; standard: consistent with the statutory review period table, with the four-category exception self-check done for Class 2.
• □ Substantial equivalence — comparison table built across the six elements; standard: every element concluded and the comparator device authorized in Korea.
• □ KGMP status — judged by class with the certificate validity checked; standard: Classes 2-4 hold a valid certificate (valid 3 years), Class 1 is exempt.
• □ Periods and fees — checked against the Enforcement Rule annex; standard: values taken at 5, 25, 55, or 70 working days with the corresponding fees.
• □ Parameter table fixed — the five items of pathway, body, period, fees, and KGMP checked; standard: all five present, with a change-triggered review mechanism in place.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages MFDS approvals, certifications and notifications, prepares equivalence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com